FDA.reportPublic FDA data

Levalbuterol

Product NDC
76204-900
11-digit product format
762040900
Labeler code
76204
Product ID
76204-900_459fa0f5-35d9-d6e5-e063-6394a90a6f14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA203653
Marketing category
ANDA
Marketing start
2016-03-22
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1.25 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levalbuterol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL HYDROCHLORIDE1.25 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ1526QJM
Rxcui242754, 311286, 349590

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
3b93cc5d-8105-47d8-8ae6-077d0f655880Product name320190213
415a13b7-458d-4b44-ab20-f56d8ef7ab9dProduct name220170426
a511b237-73ca-80ef-2a42-a935d09028adProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-900-01Levalbuterol30 in 1 CARTONSOLUTION3022
76204-900-05Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-900-05Levalbuterol5 in 1 POUCHSOLUTION522
76204-900-11Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-900-11Levalbuterol1 in 1 POUCHSOLUTION122
76204-900-15Levalbuterol25 in 1 POUCHSOLUTION2522
76204-900-15Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-900-25Levalbuterol1 in 1 CARTONSOLUTION122
76204-900-55Levalbuterol5 in 1 CARTONSOLUTION522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-900-01ML - Milliliter76204-9006dc1ccae-a5ff-40b9-b469-a7d9a4c491f912017-07-07
76204-900-11ML - Milliliter76204-9001926b65b-a39d-4090-a242-df732bf60d6512017-07-07
76204-900-12ML - Milliliter76204-90095e53ee0-6be1-4d9d-a892-2c528b4a173812016-05-16
76204-900-15ML - Milliliter76204-90025cef639-b64b-4c12-b199-c37de1870ece12017-08-11
76204-900-24ML - Milliliter76204-90037345d56-b8d6-483e-bd7f-20664f94de6612016-05-16
76204-900-25ML - Milliliter76204-900aa8853e7-2a0d-4a3d-8cfb-1991f908aba012017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-900LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]20Current NDC, Legacy NDC, 9 package rows20241219_d6998949-e1cb-4c86-a480-c0dfd9cb75b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSNd6998949-e1cb-4c86-a480-c0dfd9cb75b522
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSNd6998949-e1cb-4c86-a480-c0dfd9cb75b522
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSNd6998949-e1cb-4c86-a480-c0dfd9cb75b522
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCDd6998949-e1cb-4c86-a480-c0dfd9cb75b522
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCDd6998949-e1cb-4c86-a480-c0dfd9cb75b522
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCDd6998949-e1cb-4c86-a480-c0dfd9cb75b522
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSYd6998949-e1cb-4c86-a480-c0dfd9cb75b522
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSYd6998949-e1cb-4c86-a480-c0dfd9cb75b522
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSYd6998949-e1cb-4c86-a480-c0dfd9cb75b522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76204-900-017620409000130 POUCH in 1 CARTON (76204-900-01) / 1 AMPULE in 1 POUCH (76204-900-11) / 3 mL in 1 AMPULE30 pouch2017-02-170000-00-00NoNoCurrent
76204-900-05762040900053 mL in 1 AMPULE3 mlHistorical
76204-900-11762040900113 mL in 1 AMPULE3 mlHistorical
76204-900-157620409001525 in 1 POUCHHistorical
76204-900-25762040900251 POUCH in 1 CARTON (76204-900-25) / 25 AMPULE in 1 POUCH (76204-900-15) / 3 mL in 1 AMPULE1 pouch2017-02-170000-00-00NoNoCurrent
76204-900-55762040900555 POUCH in 1 CARTON (76204-900-55) / 5 AMPULE in 1 POUCH (76204-900-05) / 3 mL in 1 AMPULE5 pouch2017-02-170000-00-00NoNoCurrent